Written statements were received from:
American Crop Protection Association

QUESTIONS FOR THE PANEL ON IMPORT TOLERANCE GUIDANCE

1. Please comment on the methodology used to determine
the number and location of crop field trials required for estimating
appropriate tolerance levels.

The Panel finds the methodologies reasonable and agrees that
the import guidance document will be a very useful step toward
harmonization of standards used in international trade. The Panel
believes that the guidance should be shared with the U.S. Delegation
to the Codex Committee on Pesticide Residues, the North American
Free Trade Agreement effort and the Organization for Economic
Cooperation and Development for their comments. The development
of a standardized guidance, when harmonizing internationally,
promotes the exchange and use of data generated among the various
countries.

A raw agricultural commodity (RAC) is a low consumption commodity
if it is less than or equal to 0.05% of the diet. The commodities
which cover this definition were identified in the DRES based
on 1977-78 food consumption survey. Information was presented
by EPA on the commodities forming a percentage of the diet. It
is recommended that these data be updated as soon as possible
to reflect current food consumption patterns of the U.S. population.

The Panel would like to see the wording on adherence to GLP's
(or their international equivalents) made stronger to indicate
that compliance to those standards is required.

2. Please comment on the criteria for limited review
of residue chemistry studies when a Codex Maximum Residue Limit
(MRL) has been established.

The Panel recognizes that increasing globalization of world
trade and consequent international movement of agricultural commodities
makes important the issue of Codex MRL's. The criteria elaborated
by the Agency for a limited review of Codex MRL's seem overly
conservative. The Panel suggests the Agency consider modifying
this approach to recognize the extent of US participation in the
establishment of MRLs. In particular there is little scientific
rationale provided for using the 0.05% consumption limitations.

The Panel suggests that the Agency consider elimination of
this restriction and instead develop a case-by-case policy which
would accept Codex MRLs as a default position, but reserving the
right to conduct a full review of the data based on the scientific
merits of each case. Under such a scheme, the Agency could require
any level of review necessary. If, based on the experience of
the US in the development of the Codex (JMPR) MRL, there were
significant scientific issues which were not adequately addressed
by the JMPR then additional review would be justified. On the
other hand, if the Agency believed that the Codex MRL was an accurate
reflection of the underlying data and no other issues pertained,
then acceptance of the MRL for limited review without restrictions
based on consumption would seem more scientifically justifiable.
Such a policy would give the Agency the flexibility to use available
resources for maximum efficiency.